Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD. A5 CANADIAN ANESTHESIA MACHINE; A5 ANESTHESIA MACHINE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD. A5 CANADIAN ANESTHESIA MACHINE; A5 ANESTHESIA MACHINE Back to Search Results
Model Number 0631B-PA00021
Device Problem No Apparent Adverse Event (3189)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/25/2022
Event Type  Death  
Manufacturer Narrative
Logs from the anesthesia system were evaluated.During the time of the reported event several "o2 supply failure" alarms were triggered.The o2 supply was correctly monitored by the anesthesia system with corresponding alarm notifications.No device malfunction was confirmed.Preventive maintenance was performed on the anesthesia system, which passed all tests.
 
Event Description
It was reported that on (b)(6) 2022 a patient expired while being monitored on a mindray a5 canadian anesthesia machine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
A5 CANADIAN ANESTHESIA MACHINE
Type of Device
A5 ANESTHESIA MACHINE
Manufacturer (Section D)
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.
1203 nanhuan ave
guangming district
shenzhen, guangming 51810 6
CH  518106
MDR Report Key16042545
MDR Text Key306075948
Report Number2221819-2022-00021
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/23/2022,11/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number0631B-PA00021
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/23/2022
Event Location Hospital
Date Report to Manufacturer12/23/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/23/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
-
-